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Fluvoxamine study #5 of 5   All Outcomes
8/23 Late treatment study
Reis et al., Preprint (Preprint)
Effect of early treatment with fluvoxamine on risk of emergency care and hospitalization among patients with COVID-19: The Together randomized platform clinical trial
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Together Trial preprint showing significantly lower hospitalization/extended ER visits with treatment, per-protocol analysis RR 0.34 [0.20-0.54]; ITT analysis RR 0.71 [0.54-0.93]. Adherence was only 73.2%. Symptom onset was unspecified or >= 4 days for 57% of patients. The schedule of study activities specifies treatment administration only one day after randomization, adding an additional day delay. Overall mortality is high for the patient population. Results may be impacted by late treatment, poor SOC, and may be specific to local variants [1, 2]. The total dose used is less than half of that in Lenze et al. Per protocol analysis is not provided for mortality. There is an unusual amount of missing data raising questions about the reliability of data overall - age is unknown for 6.5% of patients according to the sub-group analysis. Both age <=50 and >50 show better results on the primary outcome than the overall result, indicating that the relatively low treatment effect seen in this study is driven more by patients with unknown age. NCT04727424. Also see [3].
Reis et al., 8/23/2021, Double Blind Randomized Controlled Trial, Brazil, South America, preprint, 25 authors.
risk of death, 29.3% lower, RR 0.71, p = 0.26, treatment 17 of 739 (2.3%), control 24 of 733 (3.3%), odds ratio converted to relative risk.
risk of hospitalization, 20.7% lower, RR 0.79, p = 0.17, treatment 74 of 739 (10.0%), control 92 of 733 (12.6%), odds ratio converted to relative risk.
extended ER observation or hospitalization, 66.0% lower, RR 0.34, p < 0.001, treatment 541, control 609, per protocol.
extended ER observation or hospitalization, 29.0% lower, RR 0.71, p = 0.01, treatment 77 of 739 (10.4%), control 108 of 733 (14.7%), ITT.
extended ER observation or hospitalization, 32.0% lower, RR 0.68, p = 0.01, treatment 77 of 728 (10.6%), control 108 of 722 (15.0%), mITT.
risk of no virological cure, 37.0% higher, RR 1.37, p = 0.17, treatment 173 of 218 (79.4%), control 160 of 217 (73.7%), adjusted per study.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. For an individual study the most serious outcome may have a smaller number of events and lower statistical signficance, however this provides the strongest evidence for the most serious outcomes when combining the results of many trials.
All 5 studies   All Outcomes
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